Clearance Summary
BABYMEG BIOMAGNETOMETER SYSTEM received FDA 510(k) clearance under submission number K133419, sponsored by Tristan Technologies, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2014-07-21.
- Submission: K133419
- Applicant / Sponsor: Tristan Technologies, Inc.
- Clearance pathway: Traditional
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.1400
- Decision date: 2014-07-21
Classification & Regulation
This clearance is catalogued under FDA product code OLY and 21 CFR 882.1400, within the Neurology review panel as a Class II device.